The recent storms that ravaged Florida and other states affected more than homes and infrastructure. Hurricane Helene inflicted significant damage on a Baxter International drug production plant in Marion, North Carolina, that produced about 60% of all intravenous fluids in the U.S. The FDA has declared shortages of three common intravenous fluid solutions (which are regulated as “drugs”) produced by Baxter. (And Hurricane Milton narrowly missed a B. Braun facility in Florida that makes another 25%.)
As a result, many hospitals nationwide are delaying non-urgent surgery and substituting oral electrolyte fluids such as Gatorade and Pedialyte for IVs. Shortages are expected to continue for months, according to a letter sent by the U.S. Department of Health and Human Services to hospitals.
Many patients and physicians are very familiar with this dilemma. Dr. Deborah Greenhouse, a pediatrician in South Carolina, tweeted this:
OK, pediatricians, I’m starting a new contest: Who can rack up the highest number of patient calls and texts in one day from parents who can’t find a pharmacy with their child’s #ADHD medication? I’m at 6 so far this morning. Do I win?
That followed a tweet of hers on the same theme several months earlier:
Today: I tried to prescribe amoxicillin for an ear infection: The pharmacy didn’t have it. I tried to prescribe Tamiflu for the flu. The pharmacy didn’t have it. I tried to prescribe Adderall for ADHD. The pharmacy didn’t have it. If that doesn’t bother you, it should.
It does bother me, and it has for a long time.
Scope of the challenge
Several years ago, University of Chicago researchers surveyed 719 pharmacists at large and small hospitals across the country and all reported experiencing at least one drug shortage in the previous year; 69% had experienced at least 50 shortages in that time. The majority were generic injectable pharmaceuticals commonly used in hospitals, including analgesics, cancer drugs, anesthetics, antipsychotics for psychiatric emergencies, and electrolyte solutions needed for patients on IV supplementation.
Many common drugs are produced primarily by a single company or a small number, so contamination, natural disaster, fire, or business failure can rapidly and radically affect the availability of a product. As a result, hospitals are continually struggling to ensure adequate supplies of drugs in shortage or to find substitutes for them.
The study found that one-third of hospitals had to ration drugs at least once. That means some patients got the second or third choice of drug treatment, increasing the likelihood that the drug would be ineffective, suboptimally effective, or have unacceptable side effects. Because of Hurricane Helene’s damage to the Baxter IV fluids plant, almost all U.S. hospitals are currently impacted in this way.
Federal officials are scrambling to find supplementary supplies of IV fluids: Within a week of the storms, the FDA said that it had begun to authorize imports of IV products from Baxter plants in Canada, Ireland, the United Kingdom, and China. The updates below were issued by the FDA’s Center for Drug Evaluation and Research (CDER).
Another example of the need to allow U.S. distributors to acquire drugs from abroad occurred recently during a shortage of penicillin here. According to a report in Reuters, Mark Cuban’s Cost Plus Drug Company reported that it was working with the FDA to temporarily import and distribute penicillin into the country. The online pharmacy, which offers low-cost, commonly prescribed medications, said that it would import and distribute 1.2 million units of penicillin from Portugal-based Laboratórios Atral S.A. to mitigate the shortage of Pfizer’s Bicillin L-A.
What should be done?
This case-by-case negotiation to address drug shortages is inefficient and unwieldy. Instead, we should prevent the shortages from occurring. We need a policy change that would enable overseas manufacturers to sell all drugs and medical devices in the United States that already have received marketing approval from foreign governments that have standards comparable to those of the U.S. FDA – the UK, EU, Scandinavian countries, Japan, Australia, and New Zealand — and vice versa. In a word, reciprocity.
Approval in one country on the list would be reciprocated automatically by the others (subject to the creation of approved labeling in the appropriate format and language, and other formalities). That would afford drugmakers in those countries rapid access to the U.S. market, helping to alleviate our shortages and preventing future ones. By making additional drugs available in the U.S., it might even put downward pressure on drug prices.
The stage is set for reciprocity of approvals. The U.S. has participated in international deliberations that have led to harmonized standards between the FDA and its foreign counterparts. Many countries now have a standardized dossier for seeking approval of new drugs; the U.S. accepts research conducted in other countries to support drug and medical device approvals; and the FDA has established Current Good Manufacturing Practice (CGMP) Regulations for foreign production facilities.
Americans need to be assured of the availability of pharmaceuticals in the marketplace so that healthcare providers have more reliable inventory, experience fewer shortages, and have more choices when shortages arise. Reciprocity of drug regulatory decisions would help to achieve that, and the White House and Congress should implement it without delay.
Note: An earlier version of this article was published previously by the American Council on Science and Health.
Henry I. Miller, a physician and molecular biologist, is the Glenn Swogger Distinguished Fellow at the American Council on Science and Health. He was the founding director of the FDA’s Office of Biotechnology. Find Henry on X @HenryIMiller.
